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Philips • Suzhou, Anhui, China
Role & seniority: Repair Quality Engineer (mid-level to senior, depends on experience)
Stack/tools: Quality Management System compliance; APQP; CAPA; process audits; data analysis; regulatory alignment; cross-functional coordination with Regulatory Affairs, R&D, IT/Q&R, Procurement, Supplier Quality
Ensure QMS compliance and lead/participate in quality governance, audits, CAPA, and continuous improvement initiatives
Perform APQP activities, write and close Quality Plans, review repair Documentation, and oversee non-conformance and KPI monitoring
Provide quality guidance to projects, liaise with Regulatory Affairs, R&D, Operations, and external partners; support regulatory assessments
Experience in Quality Engineering or related field; 2+ years with Bachelor’s or Master’s (or Master’s with no experience)
Process quality management, root cause analysis, CAPA methodologies
Data analysis, DFQ, regulatory requirements, process monitoring, technical documentation
Strong cross-functional collaboration and audit/controls mindset
Job Title Repair Quality Engineer Job Description Job Responsibilities: Ensuring compliance with the Quality Management System, in accordance with Philips Policy, applicable worldwide regulations and standards. Providing guidance on Quality topics for Business Partner: Repair Sustainability Services (RSS)/ Service Parts Supply Chain (SPS) Supporting the execution of Project Quality and Regulatory assessments Acting as a liaison between departments such as Regulatory Affairs, Business Q&R and R&D Software/IT Q&R, Procurement, Supplier Quality and with Legal Manufacturers. Identifying and implementing improvement opportunities within the organization, either directly or through cross functional teams Supporting Corrective and Preventative Actions (CAPA) as a Subject Matter Expert Lead / support internal and external audits Carry out process audits targeting lean improvement opportunities to drive continuous improvement Perform and document Advanced Part Quality Plan (APQP) activities, in close connection with the responsible business to ensure new capabilities are established with the highest quality standards Writing Quality Plans and ensuring the execution and closure of such plans Provide quality guidance and support for project governance, providing progress reporting in appropriate governance meetings. Review and approval of repair documentation and records as required by relevant Engineering and Operations teams, ensuring execution of quality control requirements Ensure effective management and control of product non-conformance, monitoring all applicable KPI’s to ensure quality standards are maintained and improved Manage customer and market quality issue including compliant and feedback Provide training on Quality related topics as required Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent. Minimum required Experience: Minimum 2 years of experience with Bachelor's in areas such as Quality Engineering, Safety Engineering, Process Engineering or equivalent OR no prior experience required with Master's Degree. Preferred Skills: • Process Quality Management • Data Analysis & Interpretation • Design for Quality (DFQ) • Root Cause Analysis (RCA) • CAPA Methodologies • Regulatory Requirements • Manufacturing Processes • Process Monitoring • Privacy, Safety and Security Risk Assessment • Technical Documentation • Process Engineering • Continuous Improvement How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights